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Just to remind everyone about the FDA blackbox warnings on Lindane



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  #1  
Old Mar 05, 2007, 09:55 PM
Registered User
Join Date: Sep 2005
Exclamation Just to remind everyone about the FDA blackbox warnings on Lindane

Some doctors still prescibing by phone, this worries me

Also there is a very long lists of medications that are contradicted with lindane.

Please see link from FDA:

http://www.fda.gov/cder/drug/infopag...ne/default.htm

Also regarding lindane lotion
http://www.lindane.com/pdf/EPA-Revis...2002-07-31.pdf


Anticipated Label Changes - According to the FDA, the label for the 1% scabies treatment lotion will be revised to restrict use to, "patients who have attained adult stature, or
approximately 60 kg". The label will also be revised to recommend only that a thin layer of lotion be applied.

The current label prescribes the following; "Use only enough to cover the body in a
thin layer. 1 ounce (half a 2 ounce container) should be all that is needed for children under 6 years of age: 1-2 ounces for older children and adults". HED conducted its scabies MOE
assessment based on directions provided in the current label.

Given anticipated label changes, use in accordance with the revised label would eliminate risks to young children (less than 60 kg).
Also, according to FDA, pending label changes to the amount of lotion required should result in lower application rates for both older children and adults.


Last edited by Pamela8 : Mar 06, 2007 at 08:24 AM. Reason: edit for copyright purposes
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  #2  
Old Mar 06, 2007, 08:49 AM
sirI's Avatar
Iris backwards, Co-Administrator
Join Date: Jun 2005
Re: Just to remind everyone about the FDA blackbox warnings on Lindane

Thank you for the reminder, Pamela8.

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  #3  
Old Mar 12, 2007, 04:40 PM
VickyRN's Avatar
Nursing Champion
Join Date: Mar 2001
Re: Just to remind everyone about the FDA blackbox warnings on Lindane

Thank you for this important information.

Lindane shampoos and lotions (commonly known as Kwell) should be used for headlice and scabies only if an alternative therapy has failed or if safer medications are not tolerable. Should not be used by children, nursing or pregnant women, individuals with known seizure disorders, or on open skin. Should only be used once; no repeat. Lindane is absorbed through the skin. Only 1-1/2 teaspoons of lindane taken orally will kill a man.

SE: seizures, neurotoxic reactions, death.

Lindane can cause seizures and damage to the nervous system, and can weaken the immune system. Case-controlled research shows a significant association between brain tumors in children and the use of lindane-containing lice shampoos. The insecticide is also a suspected carcinogen and hormone disruptor.

http://www.mosbysdrugconsult.com/Dru...lindaneScabies

http://www.fda.gov/cder/drug/infopag...ne/default.htm

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5421a2.htm

http://mysite.verizon.net/vzetu8ii/p...ndane/id3.html

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  #4  
Old May 19, 2008, 07:37 PM
Super Moderator
Join Date: May 2000
Re: Just to remind everyone about the FDA blackbox warnings on Lindane

WHen I was about 22, I found out the hard way when the hardware store guy told me how to "dip" my dogs in lindane in a deep trash can. They did fine. The water came up to my elbows and I think I had like 5 dogs at the time. I got all ataxic, blurry vision, the whole 9 yards. I weighed about 105 at the time and was NOT a nurse. Fortunately my FIL was about a block away and got me to the doctor.

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Just to remind everyone about the FDA blackbox warnings on Lindane

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